NCTN Navigator: Proposal Submission Process
NCTN Navigator makes more than 2.5 million specimens that were banked via NCTN trials visible and accessible to the translational medicine research community. The NCTN database catalogues the specimen characteristics along with the associated clinical information that was collected throughout the conduct of the associated clinical trial.
Via the “Explore Specimens” link at the top right of the page on the NCTN Navigator website, investigators can search the inventory of banked specimens and filter results by any of the following individual characteristics or combination thereof:
- Trial Characteristics: Trial ID, Lead Network Group, Agents, Primary Diagnosis, Study Design (Phase and Type), Keywords,
- Patient Demographics: Gender, Age, Race, Ethnicity,
- Specimen Characteristics: Clinical Time Point, Anatomical Source, Specimen Type, Preservation Status or Pathological Status.
The subset of SWOG’s resources that are currently housed in the NCTN Navigator database includes 200,000 (soon to grow to 300,000+) biospecimens from 16,000+ participants who were enrolled to 20 SWOG trials.
Most approved NCTN Navigator TM proposals test a specific hypothesis or validate a biomarker rather than being exploratory, although hypothesis-generating and exploratory studies can get approval for use of biospecimens collected from negative clinical trials.
NCTN Core Correlative Sciences Committee (CCSC) Application and Approval Process
- The review process involves submission of an LOI for feasibility review.
- The LOI will include the project title, proposal hypothesis, identify the requested specimens and associated data elements, and whether there is interest in collaboration with the Group that led the conduct of the associated clinical trial.
- The LOI will be determined to be feasible or not feasible.
- After the LOI is accepted (deemed feasible), an in-depth proposal must be submitted for CCSC review.
- Proposal sections include: Objectives and Hypotheses, Background and Significance, Research Design and Methods, Statistical Considerations, and Required Attachments (letters of collaboration from co-investigators and the completed feasibility report confirming the availability of requested specimens and data).
- The CCSC may approve, disapprove, or grant approval on hold.
- If the CCSC grants approval on hold, there may be multiple rounds of proposal re-submission to provide requested clarification or revisions prior to CCSC full approval of the proposal.
Getting started:
- To submit a Letter of Intent (or application), login to the NCTN Navigator system. You must have active CTEP credentials to submit an LOI.
- Refer to NCTN Navigator Steps for Researchers for a quick overview of how to get started, the NCTN Navigator FAQs for helpful information pertaining to the logistics and timing of LOI and subsequent proposal process, and the User Manual, which provides step-by-step instructions for submission of both the LOI and subsequent proposal through the NCTN Navigator portal.